Brand & Product Security

Articles

Grows Syner-G’s presence in RTP, a biotech hub that continues to develop

Syner-G BioPharma Purchases Impact Pharmaceutical Services

Following a November FDA public meeting, HDA reiterates the objections it had to guidance FDA issued in mid-2021 under the Drug Supply Chain Security Act (DSCSA)

HDA takes another swing at FDA’s proposed DSCSA guidance

Merger with Phlexglobal expands provider’s technological capabilities 

PharmaLex furthers its clinical and regulatory reach

In a civil action, Gilead alleges an extensive, transnational counterfeiting ring of HIV and other drugs

Gilead’s case against an alleged $250-million counterfeiting ring—what happens next?

Acquisition of AcKnowledge RS also expands company's IVD expertise

RQM+ furthers regulatory knowledge with consulting firm purchase

Pandemic notwithstanding, the agency maintained a steady pace in 2021 in clearing important new therapies, including new vaccines and drugs for Covid

No slowing of approval train at FDA 

Emergency-use clearance of Pfizer drug a major milestone in the fight against the now-omicron-fueled virus in the US  

First Covid antiviral pill wins FDA authorization

Building a data-sharing system for the US Drug Supply Chain Security Act (DSCSA) is two years from a mandated completion—will industry be ready?

Ups and downs in the march to DSCSA compliance

Biden touts provisions administration believes can curb spending on pharmaceuticals

Drug costs central issue in budget battles

Exploring the FDA’s latest proposed guidance on computer system validation, and the movement toward a less burdensome approach

Legal & Regulatory